Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an approved new animal drug application (NADA) from Heska Corp. to Pharmacia & Upjohn Co.
This rule is effective July 26, 2000.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Thomas J. McKay, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0213.End Further Info End Preamble Start Supplemental Information
Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525, has informed FDA that it has transferred to Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199 ownership of, and all rights and interests in NADA 141-082. Accordingly, the agency is amending the regulations in 21 CFR 522.778 to reflect the transfer of ownership.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.Start List of Subjects
List of Subjects in 21 CFR Part 522
- Animal drugs
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows:End Amendment Part Start Part
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation for 21 CFR part 522 continues to read as follows:End Amendment Part
2. Section 522.778 Doxycycline hyclate is amended in paragraph (b) by removing “063604” and adding in its place “000009”.
Dated: July 18, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 00-18825 Filed 7-25-00; 8:45 am]
BILLING CODE 4160-01-F